阿奇霉素缓释阴道栓的质量控制

Quality Control for Azithromycin Sustained Release Suppository

目的:对阿奇霉素缓释阴道栓进行质量控制。方法:采用薄层色谱法(TLC)鉴别阿奇霉素缓释阴道栓中的阿奇霉素,用反相高效液相色谱法测定其中阿奇霉素的含量;以pH6.0磷酸盐缓冲液为释放介质,采用《中国药典》2005年版二部释放度测定法中的第一法测定累积释放率并进行体外释药模型的拟合。结果:TLC鉴别方法专属性强,阿奇霉素检测浓度线性范围为50～800μg·mL^(-1)(r=0.9998);平均回收率为100.56%,RSD<1.84%(n=6);体外释放模型符合Higuchi方程。结论:所建立的阿奇霉素缓释阴道栓质量控制方法可靠、准确、专属性强,且制剂的体外释放符合缓释标准。

OBJECTIVE：To establish the quality standard of azithromycin sustained release suppository.METHODS：TLC was applied for the identification of azithromycin and the content of azithromycin in the suppository was determined by HPLC.According to dissolution determination method stated in Chinese Pharmacopeia（2005 edition）,accumulative dissolution of azithromycin sustained release suppository was determined using phosphate buffer as dissolution medium,and in vitro dissolution model was fitted.RESULTS：The identification method has a good specificity.The linear range of azithromycin was 50～800 μg·mL^-1（r= 1 0.999 8）with an average recovery of 100.56%（RSD〈1.84%,n=6）.In vitro release model conformed with Higuchi equation.CONCLUSION：Established method is reliable,specific and accurate,drug release of suppository in vitro is in line with standard.